Social Experiences and Demographic Factors in the Regulation of Immune Cells

Morgan State University

Status: Enrolling

Conditions: Perceived Discrimination; Inflammatory Response; RNA

Treatments: Behavioral: Cyberball

Study type: Interventional

Funder types: Other

Identifiers

NCT06519487

2407001

Details and patient eligibility

About

Immune-mediated inflammatory diseases are a health burden for approximately seven percent of the population of Western nations. Preliminary data suggest variations in ethnic identity and/or geography influence discrimination experiences and inflammatory response trends. This study investigates how geography, ethnicity, and laboratory manipulation of discrimination experiences affect immune cell function and genomic regulation. Flow cytometry and immune cell stimulation will test monocytes collected from peripheral blood for functional effects. Next-generation transcriptomics and epigenomics will assess genomic and epigenetic mechanisms. The hypothesis is that geography, self-identified race, and ethnicity, interacting with laboratory discrimination conditions during the virtual ballgame Cyberball™, significantly affect immune cell function through genomic and epigenetic mechanisms, with perceived discrimination as a moderating factor on the immune outcomes. The transdisciplinary nature of the proposed study aims to provide valuable insights into differential susceptibility to immune-mediated inflammatory diseases across diverse populations. Uncovering these insights will better inform population-relevant interventions for immune-mediated inflammatory diseases.

Full description

More than a third of the residents of the United States suffer from a chronic disease, with almost half involving dysregulated immune processes. Immune-mediated inflammatory diseases pose a public health burden in the United States. Preliminary data from previous work suggest that variations in ethnic identity and geography might influence discrimination experiences and inflammatory response trends. To investigate the functional implications of these findings, a multi-institutional study is proposed, examining how social experiences and demographic factors predict the regulation and activity of immune cells. Specifically, the hypothesis is that geography, self-identified race, and ethnicity, interacting with laboratory discrimination conditions, significantly affect immune cell function through genomic and epigenetic mechanisms, with perceived discrimination moderating the immune outcomes. Participants will provide saliva samples, complete psychosocial and demographic questionnaires, and play the virtual social exclusion game Cyberball™ in a randomly assigned block order. Acute discrimination experiences are manipulated by conditions during Cyberball. Virtual players, who appear to be of a different race from the participant, exclude them by not passing the participant the ball in the race-based exclusion condition. In the inclusion condition, the participant receives the ball regardless of participant and virtual player race. In the general social exclusion (not race-based), the players and participant races are similar to the inclusion condition, except that the participant does not receive the ball. The block of Cyberball and blood draws randomly assigned are either: 1) race-based social exclusion and inclusion first, a blood draw, then non-race-based social exclusion, inclusion, and blood draw, or 2) non-race-based social exclusion and inclusion, a blood draw and then the race-based social exclusion and inclusion and a blood draw. Baseline and post-first block inflammatory responses in saliva will be measured using enzyme-linked immunosorbent assays (ELISAs) to determine the concentration of cytokines like C-reactive protein, interleukin-6, and tumor necrosis factor-alpha. Flow cytometry and immune cell stimulation with toxin will test monocytes purified and sorted from the participant's blood for functional effects. Next-generation transcriptomics and epigenomics will assess differentially expressed RNA and methylation enrichment, emphasizing genes involved in inflammation signaling pathways. The data will be statistically analyzed using regression analysis and structural equation modeling to determine the relationship between discrimination, geography, immune cell function, and regulation while controlling for other socio-demographic factors. The findings could inform public health initiatives and interventions to reduce health disparities and improve outcomes for marginalized communities.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Non-Hispanic Black, Non-Hispanic White, or Hispanic
• At least 18 years of age
• Lives within 25 miles of, works, or attends Morgan State University, The University of Baltimore or Texas Christian University

Exclusion criteria

• Anyone not identifying as either non-Hispanic Black, non-Hispanic White, or Hispanic,
• Under 18 years old
• Does not live within 25 miles of, works, or attends Morgan State University, the University of Baltimore or Texas Christian University

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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480 participants in 12 patient groups

Mid-Atlantic: Non-Hispanic Black Order 1

Experimental group

Description:

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any obvious ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth with each other a number of times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Treatment:

Behavioral: Cyberball

Mid-Atlantic: Non-Hispanic Black Order 2

Active Comparator group

Description:

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Treatment:

Behavioral: Cyberball

Mid-Atlantic: Non-Hispanic White Order 1

Experimental group

Description:

Participants play Cyberball™ with virtual players who appear non-Hispanic Black, or Hispanic. The participant receives the ball once during the game, while all the non-Hispanic Black or Hispanic avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Treatment:

Behavioral: Cyberball

Mid-Atlantic: Non-Hispanic White Order 2

Active Comparator group

Description:

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball with virtual players who appear to be non-Hispanic Black or Hispanic. The participant receives the ball once during the game, while all the non-Hispanic Black or Hispanic avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Treatment:

Behavioral: Cyberball

Mid-Atlantic Hispanic Order 1

Experimental group

Description:

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant receives the ball once during the game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Treatment:

Behavioral: Cyberball

Mid-Atlantic Hispanic Order 2

Active Comparator group

Description:

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Treatment:

Behavioral: Cyberball

Southwest Non-Hispanic Black Order 1

Experimental group

Description:

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Treatment:

Behavioral: Cyberball

Southwest Non-Hispanic Black Order 2

Active Comparator group

Description:

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Treatment:

Behavioral: Cyberball

Southwest Non-Hispanic White Order 1

Experimental group

Description:

Participants play Cyberball™ with virtual players who appear non-Hispanic Black or Hispanic. The participant receives the ball once during the game, while all the non-Hispanic Black or Hispanic avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the different avatars, regardless of ethnicity.

Treatment:

Behavioral: Cyberball

Southwest Non-Hispanic White Order 2

Active Comparator group

Description:

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. Participants play another session of Cyberball with virtual players who appear to be non-Hispanic Black or Hispanic. The participant only receives the ball once during the entire game, while all the non-white avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Treatment:

Behavioral: Cyberball

Southwest Hispanic Order 1

Experimental group

Description:

Participants play Cyberball™ with virtual players who appear to be non-Hispanic White. The participant only receives the ball once during the entire game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing saliva and blood samples, participants play Cyberball, in which they receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity. During this round, participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participant again only receives the ball once during the entire game, while the other avatars that look similar to them pass the ball back and forth several times. After completing surveys and providing blood samples, participants receive the ball from virtual players an equal number of times as the other avatars, regardless of their ethnicity.

Treatment:

Behavioral: Cyberball

Southwest Hispanic White Order 2

Experimental group

Description:

Participants play Cyberball with virtual players who do not have any noticeable ethnic differences from them. The participants only receive the ball once during the entire game, but avatars that look similar to them pass the ball back and forth with each other several times. After completing surveys and providing saliva and blood samples, participants play Cyberball again but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity. Participants play another session of Cyberball™ with virtual players who appear to be non-Hispanic White. The participant receives the ball once during the game, while all the non-Hispanic White avatars will pass the ball back and forth with each other many times. After completing surveys and providing blood samples, participants again play Cyberball but receive the ball from virtual players an equal number of times as the other avatars, regardless of the avatars' ethnicity.

Treatment:

Behavioral: Cyberball